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Immunosuppressant
Once Daily Dosing for Kidney Transplant (OnceDaily Trial)
N/A
Waitlist Available
Led By John Gill, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 30 Other Conditions
No Placebo-Only Group
Summary
This trial is testing whether giving all medications once a day, instead of the current twice-daily schedule, will improve patient adherence and satisfaction.
Who is the study for?
This trial is for kidney transplant recipients aged 12 and older who are at least one year post-transplantation, on specific immunosuppressants, and considered low risk. It's not for those with high antibody levels, unstable graft function, active infections or malignancies, or a history of non-adherence.
What is being tested?
The study tests if switching patients to once-daily medication regimens improves adherence and satisfaction. This includes converting to Advagraf (a once-daily immunosuppressant) and adjusting other meds to a single daily dose.
What are the potential side effects?
Potential side effects may include typical reactions associated with immunosuppressive medications such as increased infection risk, possible drug interactions due to the new dosing schedule, and any individual intolerance to medication changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility: Number of patients successfully converted to a once daily dosing regimen
Number of patients not meeting safety criteria
Secondary study objectives
Patient Adherence to Dosing Regimen
Patient Satisfaction
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 30 Other Conditions
This treatment demonstrated efficacy for 30 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Conversion to once daily dosingExperimental Treatment3 Interventions
The conversion to a once daily dosing regimen will be accomplished in three phases (1-conversion to Advagraf; 2-conversion of non-immunosuppressant drugs and; 3-conversion of patients taking twice daily MPA to once daily MPA). No control group.
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,466 Previous Clinical Trials
2,485,380 Total Patients Enrolled
Astellas Pharma Canada, Inc.Industry Sponsor
23 Previous Clinical Trials
3,522 Total Patients Enrolled
John Gill, MDPrincipal InvestigatorSt. Paul's Hospital
3 Previous Clinical Trials
473 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had treatment to reduce your body's reaction to certain proteins or blood type differences in the past.Your Panel Reactive Antibody (PRA) level is 30% or higher before the transplantation.People who are at least 12 years old and adults who are at least 18 years old.You are taking medications like tacrolimus, cyclosporin, or Advagraf.You have only had one transplant and are considered low risk by the main doctor before being asked to join the study.Your transplanted kidney is not working well, and you have experienced rejection or other specific kidney problems in the past.You have an ongoing infection or are getting treated for a long-term infection.Your kidneys are not filtering blood properly.You have any type of cancer that is currently growing or spreading, except for non-melanoma skin cancer.You are taking too many different medications to switch to a once-a-day medication.You must have received a kidney transplant at least 12 months ago.You have been taking a specific amount of mycophenolate medication daily for the past 3 months, and it's important to stick to the prescribed amount.You are taking a different medication than mycophenolate mofetil or mycophenolate sodium, or you are not taking any of these drugs.Children who are at least 14 years old and receiving treatment at British Columbia Children's Hospital.You had a kidney transplant at British Columbia Children's Hospital at least 12 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: Conversion to once daily dosing
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 30 Other Conditions - This treatment demonstrated efficacy for 30 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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